UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012283 |
|---|---|
| Receipt number | R000014364 |
| Scientific Title | Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2018/01/25 15:50:25 |
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Basic information
Public title
Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Acronym
LEM on AIT for Cancer
Scientific Title
Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Scientific Title:Acronym
LEM on AIT for Cancer
Region
| Japan |
Condition
Condition
Incurable cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical and immunological analysis on the effect of LEM in the adoptive immunotherapy using autologous activated lymphocytes in patients with incurable cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immunological activity
Key secondary outcomes
QOL, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
LEM 1800mg/day, twice a day, orally, 4weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically-defined panreatic cancer
2) Measurable lesion
3) on-going AIT
4) Age 20-80
5) PS 0-2
6) Estimated prognosis >= 3 months
7) Sufficient organ function
WBC>4,000/mm3, <12,000/mm3
NE>2,000/mm3
PLT>100.000/mm3
Hg>10.0g/dl
GOT/GPT<Normal range x 2
Bil<1.5mg/dl
Creat<1.5mg/dl
8) Written informed consent
9) No pregnancy
Key exclusion criteria
1) Autoimmune disease
2) Uncontrollable complications including
infection, diabetes, hypertension, ischemic heart disease, cerebral infarction, interstitial pneumonitis, cancer pain
3) Pregnancy
4) Allergy
5) General symptoms including dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, difficult for out-patient
6) Steroid or immunosuppressive agents
7) Other unacceptable reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki YAMAGUCHI |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
Address
Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
shogo@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki YAMAGUCHI |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
Address
Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
shogo@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 13 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014364
